Home NDC 66758-071 CILOXAN
Product NDC 66758-071
11-digit product format 667580071
Labeler code 66758
Product ID 66758-071_930a2e4b-dcac-4a27-a073-fd21622c1666
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ciprofloxacin hydrochloride
Dosage form OINTMENT
Route OPHTHALMIC
Labeler Sandoz Inc
Application NDA020369
Marketing category NDA
Marketing start 1998-06-02
Substance CIPROFLOXACIN HYDROCHLORIDE
Active strength 3 mg/g
Pharmacologic classes Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020369-001 CILOXAN CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base CILOXAN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIPROFLOXACIN HYDROCHLORIDE 3 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4BA73M5E37 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 213307 Internal RxNorm lookup 309306 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66758-071-38 CILOXAN 3.5 g in 1 TUBE OINTMENT 3.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66758-071 CILOXAN (CIPROFLOXACIN HYDROCHLORIDE) OINTMENT [SANDOZ INC] 2 Current NDC, 1 package rows 20250413_09ca5374-2a16-4a95-91b3-70591d78254e.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 66758-071-38 66758007138 3.5 g in 1 TUBE (66758-071-38) 3.5 g 2025-03-28 No No Current